Trial Outcomes & Findings for Transnasal Induction of Normothermia in Febrile Stroke Patients (NCT NCT03360656)

NCT ID: NCT03360656

Last Updated: 2023-06-18

Results Overview

Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2023-06-18

Participant Flow

Participant milestones

Measure	Transnasal Thermal Regulating Device Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours Transnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transnasal Induction of Normothermia in Febrile Stroke Patients

Baseline characteristics by cohort

Measure	Transnasal Thermal Regulating Device n=30 Participants Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours Transnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	61.93 years STANDARD_DEVIATION 15.87 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Population: The primary efficacy analysis for cooling performance will be based on the evaluable populations of subjects who undergo cooling treatment with the COOLSTAT System. Analysis will be performed on treatment initiated and treatment completed populations. Subjects who achieve normothermia (core temperature ≤ 37.5 °C) within 4 hours of starting COOLSTAT treatment and maintain normothermia for the duration of the treatment will be determined to have been treated successfully.

Ability of transnasal thermal regulating device to reduce core body temperature within 4 hours of initiation

Outcome measures

Measure	Transnasal Thermal Regulating Device n=30 Participants Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours Transnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
Cooling Performance	19 Participants

Adverse Events

Transnasal Thermal Regulating Device

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Transnasal Thermal Regulating Device n=30 participants at risk Consented subjects will undergo cooling via transnasal thermal regulating device for a period of 8 to 24 hours Transnasal Thermal Regulating Device: Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
Nervous system disorders Shivering	30.0% 9/30 • Number of events 11 • Adverse events were collected during a 48 hour period, starting when the subject was placed on CoolStat, during the 24 hour cooling period, and for the 24 hour post-cooling observation period.
Nervous system disorders Insufficient cooling	16.7% 5/30 • Number of events 5 • Adverse events were collected during a 48 hour period, starting when the subject was placed on CoolStat, during the 24 hour cooling period, and for the 24 hour post-cooling observation period.
Cardiac disorders Adverse effects on systemic blood pressure	10.0% 3/30 • Number of events 3 • Adverse events were collected during a 48 hour period, starting when the subject was placed on CoolStat, during the 24 hour cooling period, and for the 24 hour post-cooling observation period.

Additional Information

Director of Clinical Operations

CoolTech

Phone: 2036856352

Email: channan@cooltechcorp.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place